(9 days)
Used for ultrasonic procedures: 1) All general subgingival scaling applications; 2) Periodontal debridement for all types of periodontal diseases; and 3) Endodontic procedures.
Used for ultrasonic procedures:
- . All general supra and subgingival scaling applications
- Periodontal debridement for all types of periodontal diseases .
- . Endodontic procedures
The Modified Device consists of the BOBCAT® Pro Ultrasonic Scaler with handpiece and DENTSPLY's 25K Ultrasonic Inserts.
The Scaler is a 25K ultrasonic scaler that operates over the frequency range of 23.5 - 25.7 kHz. The Scaler is available in various voltage inputs.
This 510(k) premarket notification (K033705) is for the DENTSPLY BOBCAT® PRO SCALER SYSTEM, an ultrasonic scaler. The document focuses on establishing substantial equivalence to a predicate device (K834283), rather than presenting a study with specific acceptance criteria and performance data in the context of typical AI/software medical device submissions.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information where available.
Acceptance Criteria and Device Performance
Based on the provided document, the "acceptance criteria" are implied to be the device meeting the safety and effectiveness standards such that it is substantially equivalent to the predicate device. The "reported device performance" is not quantified in the typical sense of a clinical trial or algorithm output, but rather asserted through design and material equivalence.
| Criteria | Reported Device Performance (Implied) |
|---|---|
| Safety and Effectiveness | Device is safe and effective for its intended uses. Materials are safe for dental use. |
| Intended Use Equivalence | Same intended uses as predicate device K834283. |
| Technological Characteristics Equivalence | Design modifications (electronic components, unit/handpiece material, ultrasonic inserts) do not change fundamental scientific technology or principles of operation. Materials have prior use in legally marketed devices. |
Study Details (Not Applicable as Per Type of Submission)
This submission is a premarket notification for substantial equivalence, not a clinical study or performance study in the way one would evaluate an AI or software device. Therefore, most of the requested information regarding sample size, data provenance, ground truth, experts, adjudication, and reader studies are not present or applicable.
- Sample size used for the test set and the data provenance: Not applicable. No test set mentioned for performance evaluation in the typical sense. The evaluation is based on design and material changes relative to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI or software product that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
- The type of ground truth used: Not applicable in the context of an algorithm's performance. The "ground truth" for this submission would be regulatory compliance and equivalence to a predicate device based on manufacturing specifications and material safety.
- The sample size for the training set: Not applicable. No training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.